Following positive preclinical data, simufilam development to advance with a clinical study expected to begin in H1 2026 for the potential treatment of TSC-related epilepsy Recent appointment of experienced neuroscience leaders to guide the clinical development strategy for simufilam Advanced settlement negotiations ongoing to resolve certain securities litigation; $31.25 million estimated loss contingency recorded in Q2 for resolution $112.4 million in cash and cash equivalents at June 30, 2025AUSTIN, Texas, Aug. 14, 2025 (GLOBE NEWSWIRE) — Cassava Sciences, Inc. (NASDAQ: SAVA, “Cassava”, the “Company”), a biotechnology company focused on developing novel, investigational treatments for central nervous system (CNS) disorders such as Tuberous Sclerosis Complex (TSC)-related epilepsy, today reported financial results for the...

– Received FDA approval for ZEVASKYN™ (prademagene zamikeracel), the first and only autologous cell-based gene therapy for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB) – – U.S. launch on track and first ZEVASKYN patient treatment expected in 3Q 2025, momentum building with strong patient interest at qualified treatment centers and referrals, positive insurance coverage established with multiple national and regional payers – – $226M in cash, cash equivalents, restricted cash and short-term investments as of June 30, 2025, expected to fund operations for over two years before accounting for anticipated ZEVASKYN revenue beginning in 3Q 2025 and projected profitability in 1H 2026 – CLEVELAND, Aug. 14, 2025 (GLOBE NEWSWIRE) —...

Phase 3 SELVA trial evaluating QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for microcystic lymphatic malformations completed enrollment, exceeding enrollment target by over 25%; top-line results on track for the first quarter of 2026 Top-line results for Phase 2 TOIVA trial evaluating QTORIN™ rapamycin for cutaneous venous malformations remain on track for the fourth quarter of 2025 QTORIN™ rapamycin has the potential to be the first approved therapy and standard of care in the U.S. for microcystic lymphatic malformations and cutaneous venous malformations Company plans to announce both a third clinical indication for QTORIN™ rapamycin and a second QTORIN™ platform candidate before year-end 2025 Cash and cash equivalents of $70.4 million as of June 30, 2025 are expected to fund operations...

Advancing novel programs for respiratory viruses that pose pandemic threats or risk of serious illness, including SARS CoV2 (ratutrelvir) and influenza (Tivoxavir marboxil, TXM) Prioritization of ratutrelvir, a ritonavir-free, protease inhibitor regimen in development for Acute and Long COVID, reflects the ongoing infection risk and greater need, with waning vaccine utilization A submitted HREC study will enable initiation of Phase 2 studies of ratutrelvir in newly diagnosed COVID patients, with extensions to assess rebound and Long COVID, as well as evaluation in PAXLOVID®-ineligible subjects TXM program to emphasize focus on stockpiling readiness Traws to host a Q2 2025 business update call today, August 14th at 8:30 AM ET NEWTOWN, Pa., Aug. 14, 2025 (GLOBE NEWSWIRE) — Traws Pharma, Inc. (NASDAQ: TRAW) (“Traws Pharma”, “Traws”...

PITTSBURGH, Aug. 14, 2025 (GLOBE NEWSWIRE) — Predictive Oncology (Nasdaq: POAI), a science-driven company leveraging its proprietary artificial intelligence and machine learning capabilities, extensive biorepository of tumor samples, and CLIA laboratory to accelerate oncologic drug discovery and enable drug development, today reported financial and operating results for the quarter ended June 30, 2025, and provided a corporate update. The Company reported a loss from continuing operations of approximately $2.0 million. Q2 2025 and Recent Highlights:Continued to advance preparations for an aggressive market expansion of ChemoFx®, its validated flagship live cell drug response assay, in the U.S. and de novo Launch in Europe.By testing multiple chemotherapies on a patients’ cancer cells before treatment selection, ChemoFx helps...

Q2 2025 Net Product Sales Increased 47% Year-over-Year to $3.8 Million SOLANA BEACH, Calif., Aug. 14, 2025 (GLOBE NEWSWIRE) — Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) disorders with an emphasis on GIMOTI® (metoclopramide) nasal spray, today reported financial results for the second quarter ended June 30, 2025, and provided a business update. “This quarter’s results demonstrate the commercial strength of GIMOTI and the precision of our execution,” said Matt D’Onofrio, Chief Executive Officer of Evoke Pharma. “With 47% year-over-year growth in net product sales and a 20% increase in new prescribers since the second quarter of last year, demand is accelerating from both physicians and patients. Fill rates are improving, and prescriber adoption is broadening...

Initial data from the 50 mg dose in the open label study and the adolescent PK run-in study planned for program update in September 2025 Adolescent participants from the PK run-in study and patients with FA who have not participated in prior nomlabofusp clinical studies are currently screening and enrolling in the open label study; planning to enroll children (2 to 11 years of age) directly into the open label study FDA recommended that the safety database include at least 30 participants with continuous study drug exposure for 6 months, and a subset of at least 10 participants for 1-year; large majority of safety data should be from participants receiving 50 mg nomlabofusp Published two peer-reviewed articles; the nonclinical data included in the publications were part of the data submitted to FDA to support the mechanism of action of...

ENGLEWOOD CLIFFS, N.J., Aug. 14, 2025 (GLOBE NEWSWIRE) — Atlantic International Corp. (Nasdaq: ATLN), a leading strategic staffing, outsourced services, and workforce solutions company, today announced financial results for the second quarter ended June 30, 2025, demonstrating significant operational improvements and a strengthened financial position. Second Quarter 2025 Highlights:Net loss narrowed by 81% to $10.7 million (or $0.20 per share), compared to a net loss of $54.9 million (or $1.96 per share) in Q2 2024 Service revenue was $102.9 million, with permanent placement services up 17% year-over-year. Gross profit margin improved to 11.1%, reflecting pricing discipline and efficiency. Operating cash flow was $5.0 million for the six months, improving from $(4.2) million a year ago. Enhanced financial flexibility by securing...

Revenues of $3.5 million, Weaker Gross Margin, and Net Loss MISSISSAUGA, Ontario, Aug. 14, 2025 (GLOBE NEWSWIRE) — Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, reports results for its third quarter and nine months of fiscal 2025 ended June 30, 2025 (“Q3” and “YTD”). Sales for Q3 were down for both Antigens and QAPs™, while YTD Antigens were up and QAPs were down YTD. Management DiscussionResults for Q3 were disappointing, impacted by two key events, cancellation of test-development programs by a key customer and the decline in sales to China. YTD recurring revenues of $14.4 million are slightly lower than prior year. Financial strength remains, with strong cash & equivalents and overall liquidity. New business development is proceeding well but...

VALUE Phase III Trial of EscharEx® in Venous Leg Ulcers Continues to Enroll Patients NexoBrid® Manufacturing Expansion on Track; Full Operational Capacity Expected by Year-End 2025 Additional Strategic Research Collaborations Established with Essity and Convatec Second Quarter 2025 Revenue of $5.7 Million, Up 43% from Prior Quarter Conference Call Today, August 14, 2025, at 8:30am Eastern Time YAVNE, Israel, Aug. 14, 2025 (GLOBE NEWSWIRE) — MediWound Ltd. (Nasdaq: MDWD), a global leader in next-generation enzymatic therapeutics for tissue repair, today announced financial results for the second quarter ended June 30, 2025, and provided a corporate update. “We continue to execute across our clinical, commercial, and operational objectives,” said Ofer Gonen, Chief Executive Officer of MediWound. “The VALUE Phase III trial of EscharEx®...